Back to resultsPlatelet Rich Plasma Testis Treatment for Infertile Men
Primary Purpose
Male Infertility, Nonobstructive Azoospermia, Azoospermia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Platelet rich plasma
Sponsored by
About this trial
This is an interventional treatment trial for Male Infertility
Eligibility Criteria
Inclusion Criteria:
- Men over the age of 18 diagnosed with NOA and at least one failed TESE
Exclusion Criteria:
-
Sites / Locations
- Stanford Urology ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Platelet rich plasma treatment arm
Arm Description
After consent in obtained, the patient will undergo a blood draw (12 tsp) to prepare the PRP infusion. The use of a centrifuge and an Arteriocyte Magellan kit are necessary for the PRP preparation. After injection of local anesthesia, PRP will be injected into each testicle.
Outcomes
Primary Outcome Measures
sperm present
A TESE procedure will be performed to determine if sperm are present
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05479474
Brief Title
Platelet Rich Plasma Testis Treatment for Infertile Men
Official Title
Platelet Rich Plasma Testis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigate the effect of intratesticular injection of autologous platelet rich plasma (PRP) on sperm retrieval rates and IVF outcomes in infertile men who already underwent a negative sperm retrieval. Currently, there is no alternative treatment after failed TESE. Prior series suggest that intratesticular PRP injections may improve TESE outcomes. We hope to determine whether PRP is an effective treatment for this patient population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility, Nonobstructive Azoospermia, Azoospermia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Platelet rich plasma treatment arm
Arm Type
Experimental
Arm Description
After consent in obtained, the patient will undergo a blood draw (12 tsp) to prepare the PRP infusion. The use of a centrifuge and an Arteriocyte Magellan kit are necessary for the PRP preparation. After injection of local anesthesia, PRP will be injected into each testicle.
Intervention Type
Biological
Intervention Name(s)
Platelet rich plasma
Intervention Description
Patients will undergo a blood draw (12 tsp) to prepare the PRP infusion. The use of a centrifuge and an Arteriocyte Magellan kit are necessary for the PRP preparation. After injection of local anesthesia, PRP will be injected into each testicle.
On the third month after the testicular PRP procedure, a TESE will be performed
If the procedure is successful a new IVF cycle using the sperm procured from the procedure will be done.
Primary Outcome Measure Information:
Title
sperm present
Description
A TESE procedure will be performed to determine if sperm are present
Time Frame
3 months after PRP injection
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men over the age of 18 diagnosed with NOA and at least one failed TESE, negative mapping or negative biopsy
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Satvir Basran
Phone
650-723-0948
Email
sbasran@stanford.edu
Facility Information:
Facility Name
Stanford Urology Clinic
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satvir Basran
Phone
650-723-0948
Email
sbasran@stanford.edu
12. IPD Sharing Statement
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Platelet Rich Plasma Testis Treatment for Infertile Men
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